
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at afatinib (also known as BIBW 2992) for non small lung cancer (NSCLC) in people who cannot have chemotherapy. The trial is supported by Cancer Research UK.
Doctors often treat non small cell lung cancer with chemotherapy. But some people are not well enough to have chemotherapy, or they choose not to have this type of treatment. In this trial, researchers are looking at a drug called afatinib to see if it helps people in this situation.
Afatinib is a type of biological therapy. It works by targeting a protein called epidermal growth factor receptor (EGFR).
Drugs that target EGFR are more likely to work if the cancer cells have a change () to a gene called EGFR.
Lung cancer is often linked to smoking, but people with lung cancer who have never smoked or were light smokers in the past, are more likely to have cancer with an EGFR gene change.
The aim of the study is to see if afatinib helps to stop the growth of non small cell lung cancer in people who have (or are suspected to have) a change to the EGFR gene change.
You may be able to enter this trial if you
To take part in this trial, you must have a change (a mutation) to the EGFR gene, or your doctor suspects you have a change to the gene but there isn’t a suitable sample of your cancer available to test for this, or a sample was looked at but it wasn’t possible to see if there was a change, or this type of testing is not currently available for you.
If it is suspected that you have a change to the EGFR gene, you must
If it is confirmed that you have a change to the EGFR gene, you can be a smoker and have any type of NSCLC.
As well as the above, if you have a change to the EGFR gene, you must be well enough to be up and about for at least some of each day, even if you need help looking after yourself (performance status 0, 1, 2 or 3). If it suspected that you have the gene change, you must be well enough to be up and about for at least half the day (performance status 0, 1 or 2).
You cannot enter this trial if you
This phase 2 trial will recruit 37 people. Everybody taking part has afatinib.
You take afatinib tablets every day an hour before eating or at least 3 hours after a meal. You keep a diary at home to note down when you take your tablets, any side effects you have and how much water you drink each day.
As long as you don’t have bad side effects, you can carry on taking afatinib for as long as it helps you.
If your cancer gets worse and you stop taking afatinib, the trial team will ask to take a sample of your cancer (a ). This is to learn more about the type of cancer you have and how the drug affects it.
You see the trial doctors and have some tests before you start the trial treatment. The tests include
You will have a bone scan if your doctor thinks your cancer may have spread to your bones.
You go to hospital
You have a physical examination and blood tests at each visit. You may have an ECG. You have a CT scan after 4 weeks of treatment and then every 2 months for a year. If you carry on taking afatinib for longer than a year, you then have a CT scan every 3 months.
When you finish treatment, you see the trial team every 2 months until a year has passed since you started treatment, and then every 3 months after that.
As afatinib is still quite a new drug, there may be side effects we don’t know about yet. The known side effects include
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Sanjay Popat
Boehringer Ingelheim
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University College London (UCL)
This is Cancer Research UK trial number CRUKE/10/040.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.